With the latest US Food and Drug Administration (USFDA) ban on Ranbaxy’s Punjab-based Toansa Active Pharmaceutical Ingredients (API) plant, the drug major’s ability to service the US opportunity is severely impaired. The company’s Ohm Laboratories, the only plant which has USFDA approval, manufactures drugs using API from Toansa. But post this ban, the company will perhaps have to go in for a tie-up for API sourcing.
Anmol Ganjoo, VP Research, JM Financial does not see any meaningful uptick as far as the US is concerned. "From a stock volatility standpoint there are not many facilities left for Ranbaxy which can come under regulatory scanner, so all their US infrastructure as far as manufacturing is concerned is demobilised," he told CNBC-TV18's Ekta Batra and Anuj Singhal. He is also worried about a follow up by one or other regulators.
Bino Pathiparampil, VP-Research, Institutional Equities, IIFL too says over the next couple of quarters he sees the company slipping into losses at the EBITDA level because fixed costs in these affected facilities are going to remain while the contribution from the US business will also come down drastically.
Pathiparampil further adds that the Diovan and Nexium generic launch may get delayed because of the ban on the Toansa plant. Had this ban not come through, the company would have launched the two products from the Toansa facility - that is procured API from the Toansa facility and formulated in Ohm Laboratories in the US. But now if the company has to depend on a third party for API, then product launches can get delayed by 6-12 months.
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Below is the verbatim transcript of Anmol Ganjoo & Bino Pathiparampil's interview with Ekta Batra and Anuj Singhal on CNBC-TV18.
Ekta: What is your entire analysis of Ranbaxy and what is the way forward in terms of the leftover business? How would you value it?
Ganjoo: There are a couple of thing which have happened with the latest import alert. Now you have a situation where Ranbaxy becomes the only Indian pharma company to have received four import alerts and now with this import alert even for the plant which is servicing the US opportunity currently out of home, the ability of that plant and approvals from that come under some kind of a strain. So net-net the ability of Ranbaxy to service the US opportunity is severely impaired in our view and it is unlikely that in next 12-18 months you are going to see any meaningful uptick as far as the US is concerned.
The second point is that you have seen a lot of these big Para IV filings under focus from where Ranbaxy derives most of its value from as far as the US business is concerned. I think the upside form that is going to be very little if they come at all, because what the company will now have to do is they will have to probably tie-up API sourcing etc. and as we saw in the case of Lipitor the upside can be quite restrictive. So clearly big negative from a 12-18 month standpoint as far as servicing the US opportunity is concerned, but from a stock volatility standpoint there are not many facilities left for Ranbaxy which can come under regulatory scanner, so all their US infrastructure as far as manufacturing is concerned is demobilised so to speak.
Anuj: What is your call on the stock now? In terms of earnings what kind of hit do you see next year? In the morning we had an analyst tell us that there is a possibility of negative EBITDA. Would you share that view?
Pathiparampil: I agree with that view. Over the next couple of quarters I see the company slipping into losses at the EBITDA level itself because the fixed costs in these affected facilities are going to stay while the contribution from the US business will come down drastically. So I expect EBITDA losses in the near-term.
Ekta: How would you approach the first-to-file (FTF) scenario? Do you think that they could possibly tie up with third party suppliers and maybe get something out of Diovan and Nexium generic and if they don't then what happens to Diovan and Nexium generic?
Pathiparampil: It depends on what the company has been working towards. In the normal case I would assume that the company was working towards launching those two products from the Toansa facility, I mean API from the Toansa facility formulated in Ohm Laboratories in the US in which case they are going to be impacted and tying up with another person and sourcing API from a third party is going to take time, at least 6-12 months and during that time there can be other risks which may come up to those opportunities, but if the company had backup provision to any potential issues to the Toansa plant then they could very well be on time as well. I would also add that these two are one-time opportunities and even if they come through in the full scale in the near-term still it does not add a lot of value to the stock's valuation.
Ekta: How does the business of Ranbaxy change going forward? Where do you think they are going to concentrate most of their strength now? Is it going to be more of distribution partnerships such as Ipca Laboratories as well as Alembic Pharma what they already have and maybe more focused within the domestic market and do you see any sort of repercussions on the negative side in any of the other markets because of these developments?
Ganjoo: Two things. As far as the empirical history of regulatory troubles with Ranbaxy is concerned we have seen that whenever there is intervention from one regulator and something as severe as this there is a follow up by one or the other regulator. So that is something which cannot be ruled out. Standalone on a steady state basis also Ranbaxy gets around 36-37 percent of its business from the US, so it is bad enough and a follow-up from any of the regulators in other geographies cannot be ruled out, so that clearly can be construed as a risk.
Second as far as the US is concerned you have to remember that as a consequence of approvals not coming through and Ranbaxy's ability to service the US opportunity with its own manufacturing and filing severely constrained the sales force in the US is sub-optimally utilised. So that does lend itself to a dynamic where sales forces can be used to selling some of the other products, like maybe an Ipca, an Alembic; companies who do not have front end in the US could start using that infrastructure more effectively. At the end of the day it is going to be a function of Ranbaxy's strategy. This strategy could at best be described as transitional because until Ranbaxy's own products start selling, there is not lot of merit in trying to have a sales infrastructure exerting negative operating leverage on the overall business.
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